Declaration of Interests
Expert Information
Name: Ana Vidal
Date: **___**
Declaration
I, Ana Vidal, hereby declare the following regarding my involvement in the clinical evaluation of medical devices manufactured by Legit.Health:
Financial Interests
I declare that I have no financial interests in Legit.Health or any competing organizations that could influence my professional judgment in conducting this clinical evaluation.
Professional Independence
I confirm that:
- My professional judgment is not compromised by any conflict of interest
- I will conduct this clinical evaluation objectively and in accordance with MDR 2017/745 requirements
- I will follow the principles of Good Clinical Practice (GCP) and relevant European guidelines
- Any compensation received for this evaluation is reasonable and proportionate to the work performed
Compliance
This declaration is made in compliance with:
- Regulation (EU) 2017/745 (Medical Device Regulation - MDR)
- MEDDEV 2.7/1 Rev. 4 - Clinical Evaluation Guidelines
- ISO 14155:2020 - Good Clinical Practice
- ICH-GCP Guidelines (E6 R2)
I undertake to immediately disclose any changes to this declaration that may arise during the course of the clinical evaluation.
Signature
**Signature:
**Date:___
**Place: